Medical Device Design Control (R& D)
Description
Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.
Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
Demonstrates working knowledge of product design and development.
Demonstrates working knowledge of design control process.
Tests, analyzes and solves technical problems with moderate guidance. Applies basic statistical techniques and utilizes design of experiments with moderate guidance.
Translates customer needs into design inputs; verifies design output meets design input. Works with moderate guidance.
Translates requirements into basic designs under the guidance of others. Creates and tests prototypes.
Maps the intellectual property landscape.
Has developed knowledge and skills in own job family; still acquiring / expanding fundamental knowledge and higher-level skills. Applies knowledge and skills to a variety of standard activities.
Works with moderate guidance in own area of knowledge.
Requirements
- BS in Mechanical Eng. or Biomedical Eng is required
- MS in closely related field is preferred
- 3+ years of experience in Medical Device Industry working in Product Development/ R&D
- Must have participated or led Product Development projects and established a successful track record
- Able to gather user needs, translate them to technical inputs
- Develop viable V&V (Design Verification and Validation) plans
- Working knowledge of Medical Device Risk Management
- Proven ability to assess root cause of issues and propose solutions
- Able to foresee project risk and develop mitigation plans
- Self-Starter, Agile, Flexible, Quick Learner
- Good Communicator, Good Listener
- Strong Work Ethic and practices client Values